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Steroids Versus ECP and Steroids as First-line Treatment of Grade II Acute GVHD

NCT06133192 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-11-15

No results posted yet for this study

Summary

The goal of this clinical trial is to compare as a first line of grade II skin acute GVHD sconventional treatment with steroids alone to a combination of steroids and extracoporeal photopheresis (ECP)

The primary end point will compare Freedom from treatment failure at 6 months from randomization as defined by meeting all the following 4 conditions:

* to be alive
* without relapse of the hematological disease
* without having required a new line of treatment for acute GVHD
* without initiating a systemic treatment for chronic GVHD.

Conditions

  • Graft Vs Host Disease

Interventions

DRUG

Uvadex

Uvadex use for ECP

DRUG

Steroids

steroids 2 mg/kg/d

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-09-30
Completion
2026-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06133192 on ClinicalTrials.gov